Status:
COMPLETED
Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Efavirenz
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Medicines for Malaria Venture
Conditions:
Malaria
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study assessed the effect of multiple doses of a moderate inducer of cytochrome P450 (CYP) 3A4 (efavirenz) on the pharmacokinetics (PK) of ganaplacide and lumefantrine combination. Results from t...
Detailed Description
This is an open-label, fixed-sequence, 2-period, crossover, Drug-drug interaction (DDI) study, to evaluate the effect of multiple doses of efavirenz on the single-dose PK of ganaplacide and lumefantri...
Eligibility Criteria
Inclusion
- Signed informed consent must be obtained prior to participation in the study.
- Healthy male and non-childbearing potential female participants 18 to 55 years of age inclusive, at Screening.
- In good health as determined by medical history, physical examination, vital signs, ECG and clinical laboratory tests, at Screening.
- Must weigh at least 50 kg with a body mass index (BMI) within the range of 18.0 to 29.9 kg/m2 inclusive, at Screening.
Exclusion
- Known family history or presence of long QT syndrome.
- Known history or current clinically significant arrhythmias.
- Any single parameter of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) exceeding 1.2 x upper limit of normal (ULN) and total bilirubin ≥ 1.5 x ULN or any elevation above ULN of more than one parameter of ALT, AST, GGT, ALP, or serum bilirubin at Screening or First Baseline.
- History of psychiatric illness.
- Score "yes" on item 4 or item 5 of the suicidal ideation section of the C-SSRS, if this ideation occurred in the past 6 months of Screening, or "yes" on any item of the suicidal behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the suicidal behavior section), if this behavior occurred in the past 2 years of Screening.
- History or presence of seizures.
- History or presence of duodenal ulcer, ulcerative colitis or Crohn's disease.
- Presence of active or uncontrolled thyroid disease.
- Additional protocol-defined inclusion / exclusion criteria may apply.
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05330273
Start Date
April 28 2022
End Date
November 22 2022
Last Update
January 12 2023
Active Locations (1)
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1
Novartis Investigative Site
Belfast, Northern Ireland, United Kingdom, BT9 6AD